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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`Hospira, Inc., and Samsung Bioepis Co., LTD,
`Petitioners,
`
`v.
`
`Genentech, Inc.,
`Patent Owner.
`____________
`
`Case IPR2017-00731 (Patent 7,846,441 B1)
`Case IPR2017-00737 (Patent 7,892,549 B2)
`____________
`
`Record of Oral Hearing
`Held: May 18, 2018
`____________
`
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK (via telephone), Administrative Patent Judges.
`
`
`
`
`Case IPR2017-00731 (Patent 7,846,441 B1)
`Case IPR2017-00737 (Patent 7,892,549 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`AMANDA HOLLIS, ESQUIRE
`MICHAEL DOBSZEWICZ, ESQUIRE
`BENJAMIN LASKY, ESQUIRE
`MARK C. MCLENNAN, ESQUIRE
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`ROBERT J. GUNTHER, JR., ESQUIRE
`ANDREW J. DANFORD, ESQUIRE
`STEPHANIE NEELY, ESQUIRE
`NORA PASSAMANECK, ESQUIRE
`WilmerHale
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`
`
`
`
`The above-entitled matter came on for hearing on Friday, May 18,
`2018, commencing at 10:00 a.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
`
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`Case IPR2017-00731 (Patent 7,846,441 B1)
`Case IPR2017-00737 (Patent 7,892,549 B2)
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE YANG: Good morning and welcome again
`everyone. This is a public hearing for IPR 2017- 00731 and 737
`between Petitioner Pfizer and Patent Owner Genentech. The
`challenged patents are 7,846,441 and 7,892,549. We previously
`joined Samsung Bioepis in the 737 case. The case that Samsung
`filed is IPR 2017- 01960. And per our previous order Petitioner
`Pfizer will be arguing on behalf of both petitioners.
`Now counsel, would you please introduce yourselves?
`As you can see, Judge Pollock isn’t here with us in person but he
`is joining us remotely. Judge Pollock, can you hear us fine?
`JUDGE POLLOCK: Yes, I can hear. Thank you.
`JUDGE YANG: Very good. Please.
`MS. HOLLIS: Good morning, Your Honors. This is
`Amanda Hollis from Kirkland & Ellis again. With me at the
`table is Mike Dobszewicz, Ben Lasky, and Mark McLennan from
`my firm Kirkland & Ellis as well. We also have a client
`representative again, Wendy Hsu.
`JUDGE YANG: Thank you. Welcome. And
`Petitioner Samsung Bioepis?
`VOICE: Good morning, Your Honor. (Indiscernible).
`JUDGE YANG: Thank you. Welcome. And Patent
`
`Owner?
`
`MR. GUNTHER: Good morning, Your Honor. Bob
`Gunther from the WilmerHale firm. With me is Andrew
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`Danford, also from WilmerHale, and Stephanie Neely, and Nora
`Passamaneck. And we have two client representatives with us as
`well, Laura Stordo (phonetic) and Diane Marchang (phonetic)
`from Genentech.
`JUDGE YANG: Thank you. Welcome. This is the
`second round in this month that the same parties and counsel
`appear before this panel. So you are familiar with the rules. But
`for the record, I’ll go over a few matters quickly.
`For 731, this is a partial hearing on one ground, the
`Baselga 94 and Baselga 96. We recently instituted on another
`ground following the Supreme Court’s decision in SAS and the
`agency’s guidance on that issue. The hearing for that part, if the
`parties request one, is set for August 2nd. And for today’s
`hearing, each party has 75 minutes to present its argument. The
`sequence is Petitioner, Patent Owner, and Petitioner. In the
`opening, Petitioner, you can present argument on both your case
`in chief and Patent Owner’s Motion to Amend. Patent Owner, if
`Petitioner doesn’t start with your Motion to Amend, you can start
`in your, during your response time anyhow. Please clearly
`identify the record. I need to emphasize this today, especially
`because Judge Pollock cannot see what’s on the slide. So you
`have to tell what you are presenting. So onto the demonstratives,
`thank you for emailing us the demonstratives. As usual, both
`parties objected to the other side. And as usual, we take all
`objections under advisement. For today’s argument, you are free
`to proceed as you see fit. Just bear in mind that new arguments,
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`new evidence will not be considered. And this goes not only to
`the demonstratives but also the subjects for the Motions to
`Exclude.
`
`And on to Motion to Exclude. On Wednesday, May
`16th we received an email from Petitioner stating that you intend
`to file a motion, another Motion to Exclude certain exhibits that
`Patent Owner filed on May 14th. We understand that those
`exhibits were used in the deposition of Dr. Lipton on May 10.
`We have entered that email as a Board exhibit to preserve any
`objection for the record. If Petitioner does seek to file that
`motion, you’re fine; you can go ahead and do that. But we’re
`going to expedite the briefing schedule. So we’re going to set it
`as 5/5/3, meaning from today, you have five business days,
`Petitioner, to file your Motion to Exclude. And Patent Owner,
`you have five business days after Petitioner’ motion to file your
`response. And Petitioner has another three business days after
`Patent Owner’s response to file your reply. No other papers will
`be authorized at this time. If parties are okay, this serves as an
`oral order. We’re not going to issue a paper version. And
`today’s transcript will serve as the record for the case. Okay
`with everybody?
`MS. HOLLIS: Yes, You’re Honor. Thank you.
`MR. GUNTHER: Your Honor, that’s fine for us. Can
`I ask one question with respect to the order of procedure today
`just to make sure I do it correctly?
`JUDGE YANG: Okay.
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`MR. GUNTHER: In terms of the Motion to Amend --
`JUDGE YANG: Correct.
`MR. GUNTHER: -- I will present on that during my
`time. Would I get a reply on that?
`JUDGE YANG: At this time we’re not thinking about
`that. As you are aware, in Aqua Products the Federal Circuit
`said that the Patent Owner does not bear the burden. So you
`don’t get a reply on that issue.
`MR. GUNTHER: Okay. And the only thing, and I
`don’t mean to press this point at all, Your Honor, but I just, as a
`matter of, I understand that with respect to the burden of proof.
`But there are certain things that we have to establish with respect
`to the amended claim, including responsiveness and issues like
`that. Do we, would I have an opportunity to talk about that in
`the response?
`JUDGE YANG: Can you give us just a few minutes?
`MR. GUNTHER: I’m sorry. I apologize for sort of
`throwing --
`JUDGE YANG: Not at all.
`(Recess.)
`JUDGE YANG: Mr. Gunther, you said, did you say
`you want to address the procedural issues?
`MR. GUNTHER: Well so I’m not sure exactly how
`things are going to unfold. But to the extent that the procedural
`issues are something that there is discussion of, which I suspect
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`there may be, I would ask for the opportunity to respond at least
`on those.
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`JUDGE YANG: Like you said, how about let’s see
`how things go?
`MR. GUNTHER: Let’s see how it goes.
`JUDGE YANG: Yes. Okay.
`MR. GUNTHER: Okay. Thank you, Your Honor.
`JUDGE YANG: All right. So let’s see, this is a
`public hearing, so please proceed accordingly. And again, please
`help us maintain the order during the hearing by not interrupting
`the other parties and to show them courtesy. And I’m sure
`everybody appreciates that. And so if there is no questions,
`Petitioner, would you like to reserve any time for rebuttal?
`MS. HOLLIS: Yes, Your Honor. Today I’d like to
`reserve 15 minutes.
`JUDGE YANG: Okay. All right. You may proceed
`whenever you are ready.
`MS. HOLLIS: I’m ready, Your Honor. Thank you.
`Good morning. This is Amanda Hollis, again, for the record.
`We’re here to talk about the 441 and 549 patents.
`What are the inventions that Genentech says are
`covered by these patents? For the 441 patent the invention is the
`idea to combine an anti-ErbB2 antibody with a taxoid
`chemotherapeutic agent to treat ErbB2 overexpressing cancer.
`Slide three, please. And for the 549 patent, it’s the idea to
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`combine three things: an anti-ErbB2 antibody, a taxoid, and
`another growth inhibitory agent to treat the same disease.
`Now, slide four, please, when the attorneys drafted
`claims to cover these inventions, they included some language
`effective to extend the time to disease progression in said human
`patient without increase in overall severe adverse events for the
`441 patent; and slide five, they added effective to extend the
`time to disease progression in the human patient.
`Now the Patent Holder, Genentech, took positions
`about these requirements, these elements. The first, slide seven,
`please, was in response to an indefiniteness rejection during
`prosecution when these patent claims were said to be invalid for
`indefiniteness. As the Patent Office explained, the problem was
`for all the claims that had the term “extend the time to disease
`progression,” that’s in both the 441 and 549 claims now, that is
`not defined by the claim. The specification does not provide a
`standard for ascertaining the requisite degree and one of ordinary
`skill in the art would not be reasonably apprised of the scope of
`the invention.
`And the Office said specifically it has never set forth
`what the extension of time to disease progression is relative to.
`For example, is the extension of time to disease progress relative
`to untreated patients? Patients who received the antibody alone
`or taxoid alone? These are specific possibilities that the Patent
`Office identified as out there and it was a reason why the claims
`were indefinite.
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`When Genentech responded to this, they --
`JUDGE PAULRAJ: Counsel, sorry to interrupt. Do
`you have hard copies of your demonstrative that you can
`distribute?
`MS. HOLLIS: I apologize.
`JUDGE PAULRAJ: Thank you.
`MS. HOLLIS: I was a little anxious.
`JUDGE PAULRAJ: No, no worries. Thank you.
`MS. HOLLIS: Apologies. So in response to this
`indefiniteness rejection, Genentech took a position on what this
`term meant. They said clearly the combination of an anti-ErbB2
`antibody and taxoid is administered in an amount effective to
`extend the time to disease progression relative to an untreated
`patient.
`
`So they were given options here. The Patent Office
`even suggested explicitly relative to an antibody alone or a
`taxoid alone and they chose something different. They chose
`relative to an untreated patient and they said that was clear.
`Clear from what? The specification. And as readily understood
`by a skilled oncologist. That’s what they said. And that’s how
`they overcame this rejection.
`JUDGE YANG: Counsel, for the 441 patent, there is
`also a limitation without increase in overall severe adverse
`event. Should we compare that with the untreated patients too?
`Or do you have any thoughts on that?
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`MS. HOLLIS: I believe it’s with respect to untreated
`patients as well. For consistency I think that’s what it would
`mean. Yes, Your Honor.
`Now Genentech, slide eight, please, took another
`position during prosecution to get these claims. And that was in
`response to prior art rejections. Remember that Genentech faced
`many rejections over prior art and in particular was facing
`anticipation of rejections over some 1997 references, including
`the Baselga 1997 reference. And they tried to distinguish their
`claims but that failed. So what did they do? They tried to
`antedate their invention --
`JUDGE YANG: Just to repeat, Baselga ‘97 is not
`today’s ground, is not the reference for today’s ground.
`MS. HOLLIS: Thank you, Your Honor. Yes, I didn’t
`mean to suggest that. I was just referring to the reference that
`they were distinguishing.
`When they couldn’t distinguish it, they tried to
`antedate it. And this is what they used to antedate it. Slide nine,
`please. What did Genentech tell the Patent Office showed the
`invention’s complete inception? They pointed to this plan to try
`a combination of an anti-ErbB2 antibody with paclitaxel in HER2
`positive breast cancer patients. That’s the H0648 protocol which
`is identified in the Dr. Hellman declaration and in Genentech’s
`papers. That, it’s a protocol. It’s a plan to treat patients. And
`they said that was the complete conception of the invention.
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`Now when they did that, when they said the inventor
`showed complete conception of the entire invention, including
`the extension element, there was no data that she had and no
`knowledge that this inventor had as to whether the time to
`disease progression would be extended or whether overall severe
`adverse events would be increased. And how do we know that?
`Well we know that from looking at the documents themselves.
`There is no such data. And then slide ten please?
`We know that from the inventor’s testimony. At the
`time you revised that clinical trial, you did not know whether or
`not the combination would extend time to disease progression.
`Is that right? That’s correct. Next slide, 11 please, excuse me.
`And we asked her some more about this. We asked her, so you
`didn’t do any changes to the actual drugs, is that correct? Now
`we’re, I’m asking her here about whether she had changed
`anything with respect to the molecules to give them these
`properties. And she --
`JUDGE PAULRAJ: Ms. Hollis, can you kind of take a
`step back and explain what the relevance of this background
`information is to your argument? Is it a claim construction
`issue? Or where is it going to?
`MS. HOLLIS: This part, so the first part was claim
`construction, when we were talking about the indefiniteness
`rejection. This part goes to the arguments we’re hearing in the
`Patent Owner’s response about why the Baselga references don’t
`invalidate these claims. Because as you are going to see, the
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`positions they took to get the claims out in the first place are
`inconsistent with what they are telling you now. That’s the
`point.
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`So here, again, for complete conception of the
`invention, they are saying to show that the inventor didn’t need
`to know whether the combination would extend the time to
`disease progression. And in fact at that time she said it was very
`contentious whether this combination would work at all. She
`didn’t know if Herceptin would work, much less Herceptin plus
`taxol. Those are her words on slide 11. And on slide 12, she
`went on and said, at this time there were no studies, no data, and
`no information on the combination of Herceptin plus taxol .
`So that was still sufficient for Genentech to say that
`complete invention was conceived when they were getting this
`out from the Patent Office in the first instance.
`Now Genentech’s position that you can have complete
`conception of the entire invention without any data on the
`combination, without any knowledge as to whether that
`combination would work, extends to the 549 patent as well. And
`that’s because, remember, they wrote claims to the three-way
`combination of drugs and it’s not disputed they provided no data
`at all on that combination. According to it, you don’t need data
`to show the possession of the complete invention.
`Now these are positions Genentech took to get these
`patents out in the first place. They needed to take these
`positions because otherwise they would face multiple rejections.
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`Now let’s talk about the arguments in these proceedings and
`what we’re hearing today.
`We laid out in our petitions against these patents in
`detail why we thought each element of each challenged claim
`was either disclosed or obvious or both over the prior art. In
`response, Genentech made arguments and they have one primary
`argument that goes across both petitions and both patents and I’ll
`address that first. Their other arguments are patent specific, so
`to speak.
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`The overarching primary argument by Genentech is
`that if you, that your claim construction was wrong, that the
`relative comparison for the extension of time to disease
`progression should be not to untreated patients but to a taxoid
`alone. They are saying as part of this overarching position, that
`was wrong. And if you agree and if you reverse your
`construction, then there’s no reasonable expectation of success
`for these extension aspects. That’s their overarching argument.
`It’s contingent on you reversing your claim construction, though.
`So let’s talk about claim construction first.
`Now slide 38, please. There’s no question, I just want
`to show you, there’s no question that this argument is contingent
`on the claim construction. Here’s their brief. They have a
`similar title in the 549 response under the proper claim
`construction. That of course is their view of claim construction.
`And then slide 39 shows we even asked their expert to confirm,
`you don’t provide an opinion in your declaration as to whether
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`the prior art would suggest the claimed combination of Herceptin
`and paclitaxel would extend the time to disease progression as
`compared to untreated patients, right? Right. So they also have
`no expert support under the claim construction that you have
`already adopted.
`So did you construe the claim correctly? Slide 40.
`We think you did. They took a very clear position to get this
`patent out on what this term meant. And today they are telling
`you that the right comparison is to a taxoid alone and they are
`telling you that there’s an example in the specification that
`makes that clear. That couldn’t be more opposite of what they
`told the office to get the patent in the first place. And --
`JUDGE YANG: The Patent Owner also says your
`expert, actually, said it should be compared with taxol only.
`MS. HOLLIS: Right. When they say that, they are
`taking one half of the paragraph of Dr. Lipton’s declaration and
`not showing you the second half of that declaration. He said,
`based on the specification the proper construction would be the
`comparison to the taxoid alone. But looking at the prosecution
`history, it’s this other interpretation. So he went, and then he
`said it doesn’t matter. I’ve addressed both interpretations. And
`that declaration can’t possibly, even if you read it their way and
`only focus on their excerpt, can’t possible overturn the public
`record, the disavowal in the prosecution history that they needed
`to make to get the patent in the first place.
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`JUDGE PAULRAJ: So Ms. Hollis, do you agree that
`the specification supports Patent Owner’s construction?
`MS. HOLLIS: No. Because I think you need to read
`the specification together with the prosecution history.
`JUDGE PAULRAJ: Okay. So that didn’t really
`answer my question -- I’m talking just the specification alone. Is
`there any support in the specification for your construction?
`Leaving aside the statement in the prosecution history.
`MS. HOLLIS: Yes, there is. Because it’s showing
`effectiveness period. So yes, its effectiveness compared to an
`untreated patient as well. Absolutely, Your Honor.
`So this, the position they are taking, remember, is
`exactly the opposite of what they told the Patent Office. And
`look, it’s also contrary to what their current expert in this
`proceeding says about that passage. Slide 41, please. Remember
`their argument today is, hey, when you look at that prosecution
`history statement, when you read it, even though we said it was
`clearly relative to an untreated patient, one reading that would
`believe we actually meant compared to a taxoid alone. I think
`again that’s so contrary to the plain meaning. But even their
`expert on whom they rely for this argument, we asked her about
`this. We said, so when you read that, meaning that prosecution
`history statement, and so there can be no confusion in reading
`that, that Genentech was choosing to compare to untreated
`patients rather than taxoid alone, right? Answer, right. She
`reads it like us. And so their whole argument that someone
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`reading this would actually think about it completely contrary to
`the plain words and think it means taxoid alone, it’s undercut by
`their own expert.
`JUDGE POLLOCK: Ms. Hollis?
`MS. HOLLIS: Yes, Your Honor?
`JUDGE POLLOCK: This is Judge Pollock. Can you
`
`hear me?
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`MS. HOLLIS: Yes, Your Honor.
`JUDGE POLLOCK: Wonderful. On slide 40 you have
`an excerpt from the prosecution history and it refers to page 15,
`lines 15 through 17 and page 42 and page 43 of the specification
`at the time. Would you kindly correlate that with the
`specification of the patent as issued and explain how that
`supports your position?
`MS. HOLLIS: I’m grabbing a copy of the patent
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`quickly.
`
`Your Honor, we are looking for the original
`application. But I think your question is how does the passage
`which is now in column 29 and 30 of the patent --
`MR. GUNTHER: Your Honor, I know I’m not
`supposed to speak. Can I just hand them -- I have it and I’m
`happy to give it to her.
`MS. HOLLIS: Thank you.
`JUDGE YANG: Very well.
`MR. GUNTHER: You’re welcome. Apologies.
`JUDGE YANG: No, not at all.
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`Case IPR2017-00731 (Patent 7,846,441 B1)
`Case IPR2017-00737 (Patent 7,892,549 B2)
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`MS. HOLLIS: Well Your Honor, I see page 15, lines
`15 through 17, and it says for cancer therapy efficacy can, for
`example, be measured by assessing the time for disease
`progression or determining the response rates, see the example
`below. And I believe that supports our construction. It’s not
`relative to a taxoid alone and it’s not defining it to be relative to
`a taxoid alone.
`JUDGE POLLOCK: Very well. And pages 42 and 43?
`MS. HOLLIS: Those were not in what I was provided.
`MR. GUNTHER: I’m sorry.
`MS. HOLLIS: Thank you. Hold on. For that I believe
`that corresponds to -- thank you.
`MR. GUNTHER: Sorry.
`MS. HOLLIS: Right. So 42 to 43 is discussing
`response criteria. And again, it says time to tumor progression
`was calculated from the beginning of therapy to progression.
`Again, I don’t think it defines time to disease progression or
`even requires the understanding that that be with respect to
`taxoid alone. And whatever the specification said, that was
`available to Genentech when they took the position that that, it
`couldn’t be more clear. It says clearly the combination is
`relative to an untreated patient.
`JUDGE POLLOCK: Thank you, Ms. Hollis. I sus pect
`Mr. Gunther will address this on his own time.
`MS. HOLLIS: Thank you.
`JUDGE POLLOCK: Please continue.
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`Case IPR2017-00731 (Patent 7,846,441 B1)
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`MS. HOLLIS: So Your Honors, and then we have the
`expert, as I mentioned, 41. And she sees it the same way we do,
`too. And she read that whole specification as well. So that’s
`claim construction. If you don’t reverse your claim construction
`at institution, then their whole primary argument that overarches
`both petitions goes to the wayside. Because it’s contingent on
`that. And even if you do reverse, as we showed you in
`connection with the Motion to Amend and as we can get to, we
`still show the efficacy with respect to taxoid alone, the
`reasonable expectation of successful efficacy and safety relative
`to the taxoid alone. The Baselga references, as we talked about,
`are talking about effects that are better than the taxoid alone. So
`it really doesn’t mean a distinction for the arguments here.
`So what’s left? For the 441 patent, their remaining
`arguments are no motivation to combine a taxol with Herceptin
`or anti-ErbB2 antibody. There’s no motivation to do that.
`That’s one argument that’s left on the 441. And then their other
`argument on the 441 that’s left is that there’s no reasonable
`expectation one would achieve no increase in overall severe
`adverse events.
`For the 549 patent, they are left with their criticisms
`of the Gelmon reference. So I’ll go through those arguments in
`order.
`
`On motivation, slide 16 please. Okay. Motivation,
`what was going on at the time, at the relevant time? Well it’s
`undisputed, and Genentech is the first one to say, that at that
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`time HER2 positive patients experienced horribly rapid
`progression and were in dire need of an effective therapy and
`that this would be known by people of ordinary skill in the art at
`the time before the invention. That’s their own words. Slide 17,
`please.
`
`And they also say that patients wanted a treatment
`that would help to extend their lives even if just by a few
`months. They are calling on doctors for this. That’s, again,
`Genentech’s own words about what was going on in the minds of
`people of skill at the time.
`What else did people know about at that time? Slide
`47, please. Well, it’s undisputed that they would have known
`about this Pegram reference published in March 1995. And here
`in this reference you can see it’s co-authored by folks including
`Baselga and Genentech. The Memorial Sloan Kettering Cancer
`Center is on there as well. And here those institutions are telling
`you that in pre-clinical studies they had combined the antibody
`already with a chemotherapy. This was the cisplatin
`chemotherapy in this trial. But they combined it and in the pre-
`clinical studies that these institutions conducted they found
`tumor cells, the combination elicited a synergistic and cytocidal
`effect on tumor cells. That’s what they saw in the pre-clinical
`studies. Then this same reference tells you they used the same
`combination in people and they saw good results there too. It
`says the use of the antibody plus cisplatin in patients with HER2
`overexpression resulted in response rates above that expected
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`from cisplatin alone. And the combination showed no apparent
`increase in toxicity. So this was going through the mind of
`people of ordinary skill in the art, too.
`Now just stopping here for a second, this is all
`undisputed and Genentech admits this is going on in the minds at
`the time. That we think is enough to show motivation for finding
`another combination therapy. But --
`JUDGE YANG: So counsel --
`MS. HOLLIS: Yes, Your Honor?
`JUDGE YANG: So this Pegram reference was
`published in 1998. The Baselga ‘94 was published in ‘94. So in
`between these two publications there was no other study about,
`on the antibody and taxol combination in chemo treatment?
`MS. HOLLIS: Your Honor, this was published in
`1995, this Pegram reference. There’s multiple Pegram references
`and this one was 1995.
`JUDGE YANG: Can you give me the exhibit number
`
`for that?
`
`MS. HOLLIS: Sure. Exhibit 1013. That’s in the 737
`and the Exhibit 1010 is in the 731.
`JUDGE YANG: I see. Okay. I’ve got it.
`MS. HOLLIS: Thank you. So this is out there. No
`disputes. Prior art, no dispute. It was in the mind of a person of
`ordinary skill. And we think that this alone shows some
`motivation here. But let’s talk about what Genentech is
`specifically arguing. They are saying there is no motivation
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`based on Baselga 1994 and 1996. Well okay, the law already is
`clear that you don’t have to find the motivation in the same prior
`art references you are relying on. But let’s talk about what they
`are saying because we think we still see motivation there.
`Let’s show slide 19, please. This is Baselga 1994.
`And here, what is it telling you? First, look at the title. It’s,
`they are using an anti-HER2 humanized monoclonal antibody
`alone and in combination with chemotherapy against human
`breast carcinoma xenografts. Next slide. And by the way,
`before we get there, we’re naming some of the same authors,
`Baselga, of course, and Genentech. This is Genentech’s work.
`This is Baselga’s work. Similar authors, overlap in authors with
`the Pegram study we just looked at. Next slide, please.
`And this Baselga 1994 reference goes on to say they
`tried combination treatment with paclitaxel plus 4D5. That’s the
`same exact combination, of course, that is exemplified in the 441
`and 549 patent specifications. And when they tried that, they got
`results. And the results showed a major anti-tumor activity with
`93 percent inhibition of growth in the paclitaxel combination.
`And they were trying other combination therapies, too. They
`were interested in others as well. They tried the combination of
`the antibody with Doxorubicin and they saw a good response
`there too. Not as good, but good, 70 percent tumor inhibition.
`By the way, these are the same two combination therapies that
`were in the clinical trial protocol that Dr. Hellman used to show
`her complete conception of the invention.
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`Now also not only does it say, you know, major anti-
`tumor activity, 93 percent of inhibition of tumor growth. It says
`this antibody didn’t increase the toxicity of either chemotherapy.
`In summary they say anti-HER2 monoclonal antibodies can
`eradicate well established tumors and enhance the activity of
`paclitaxel and Doxorubicin against human breast cancer
`xenografts.
`Now look, put yourself in a person of ordinary skill in
`the art’s shoes. According to Genentech, people are screaming
`for a more effective therapy. Something to help. Something to
`help just a little. They are getting calls from patients. I just
`want my life extended by, even by a little. And you see
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